BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYROVALVE

    MDR report key: 187378 · Received September 14, 1998

    Report

    Report Number
    1063481-1998-00018
    Event Type
    Injury
    Date Received
    September 14, 1998
    Date of Event
    July 27, 1998
    Report Date
    August 14, 1998
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOUR YEAR OLD FEMALE WITH MEDICAL HISTORY OF AORTIC STENOSIS AND LEFT VENTRICULAR HYPERTROPHY STATUS POST RESECTION OF SUBVALVULAR AORTIC MEMBRANE (02/1989) UNDERWENT A PULMONARY AUTOGRAFT-ROOT PROCEDURE USING A 26MM ALT-PULMONARY HOMOGRAFT ON 9/17/1991. ON 7/27/1998, PT UNDERWENT BALLOON DILATION DUE TO CALCIFICATION AND STENOSIS. THE GRADIENT WENT FROM 40MM TO 20-23MM AFTER DISSECTION OF CALCIUM FROM WALL OF HOMOGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYROVALVE Implant HEART VALVE, ALLOGRAFT MIE CRYOLIFE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| L| R